ANN ARBOR, MI , a specialty pharmaceutical company developing
innovative late-stage drug candidates for the treatment of
neurologic and fibrotic diseases, today announced that the United
States FDA has opened an Investigational New Drug Application (IND)
to conduct a double-blind, randomized, placebo-controlled Phase II
clinical trial of oral flupirtine for the treatment of
fibromyalgia, a rheumatic pain disease which affects an estimated 6
million Americans. Lyrica�, the only FDA-approved medication for
the treatment of fibromyalgia amongst other indications, recorded
$1.8 billion in sales during 2007, with 47 percent annual
growth.
Oral flupirtine has been approved as a treatment of pain in
Europe since 1981 but has never been approval for any indication in
the U.S. Flupirtine, a non-opiate analgesic, has been used in
Europe for more than 25 years for post-surgical pain, cancer pain,
trauma pain, pain associated with liver disease, and other
nocioceptive pain states. Preclinical data and clinical experience
suggests that flupirtine should also be effective for neuropathic
pain since it acts in the central nervous system. Flupirtine is
especially attractive because it operates through non-opiate pain
pathways, exhibits no known abuse potential, and lacks withdrawal
effects. In addition, no tolerance to its antinocioceptive effects
has been observed. One common link between neuroprotection,
nocioception, and flupirtine may be the NMDA (N-methyl-D-aspartate)
glutamate system, a major receptor subtype for the excitotoxic
neurotransmitter, glutamate. Flupirtine has strong inhibitory
actions on NMDA-mediated neurotransmission.
Dr. Andrew L. Stoll, director of the Psychopharmacology Research
Laboratory at McLean Hospital, a Harvard University-affiliated
teaching hospital and inventor of this program, commented, "Due to
its rapid onset of action and high response rate in
treatment-refractory fibromyalgia patients, I believe flupirtine
may represent a new therapeutic modality for the treatment of this
debilitating disease which affects more than six million Americans.
There is a strong scientific rationale supporting the development
of flupirtine for the treatment of fibromyalgia."
"For example, other NMDA receptor antagonists, such as ketamine,
have also demonstrated efficacy in fibromyalgia, but have an
unacceptable side-effect profile," Dr. Stoll continued. "Based on
the extensive database of prior human experience with flupirtine
for general pain conditions, coupled with my own experience in
treating refractory fibromyalgia patients on an individual patient
basis, I believe flupirtine may be an exciting and highly promising
treatment option to this devastating disease."
Steve H. Kanzer, Pipex's Chairman and Chief Executive Officer,
stated, "Oral flupirtine has been marketed for more than two
decades in Europe for the treatment of pain-related diseases. As we
enter this Phase II clinical trial of oral flupirtine for treatment
of fibromyalgia, the product's substantial human experience coupled
with the promising human data already generated in refractory
fibromyalgia patients, represents an exciting new approach to
treating this widespread often debilitating disease."
Mr. Kanzer went on to say, "The rapid onset of action and
mechanism of action may make oral flupirtine an attractive
treatment option in the rapidly growing projected multibillion
dollar fibromyalgia market."
During November 2005, Pipex entered into an exclusive worldwide
license to issued U.S. patent 6,610,324 and pending international
patents from McLean Hospital, a Harvard University-affiliated
teaching hospital relating to flupirtine's use to treat
fibromyalgia syndrome.
Phase II Clinical Trial of Oral Flupirtine in Fibromyalgia
This phase II clinical trial is designed as a double-blind,
placebo controlled phase II clinical trial which would evaluate
safety and efficacy of oral flupirtine vs. placebo in fibromyalgia
patients. This phase II clinical trial is intended to enroll up to
90 subjects and treat subjects for up to 90 days and the primary
endpoint will be a reduction in musculoskeletal pain and the
overall symptoms of fibromyalgia. Secondary outcomes of the study
will be a reduction in the severity of mood, fatigue, cognitive
symptoms, and sleep disturbance, as well as improve the overall
level of functioning.
About Fibromyalgia
Fibromyalgia is an arthritis-related condition that is
characterized by generalized muscular pain and fatigue. It is a
chronic and debilitating condition characterized by widespread pain
and stiffness throughout the body, accompanied by severe fatigue,
insomnia and mood symptoms. It is estimated to affect between two
and four percent of the world's population and after,
osteoarthritis, is the most commonly diagnosed disorder in
rheumatology clinics.
About Pipex Pharmaceuticals, Inc.
Pipex Pharmaceuticals, Inc. ("Pipex") is a specialty
pharmaceutical company that is developing proprietary, late-stage
drug candidates for the treatment of neurologic and fibrotic
diseases. Pipex's strategy is to exclusively in-license
proprietary, clinical-stage drug candidates and complete the
further clinical testing, manufacturing and regulatory requirements
sufficient to seek marketing authorizations via the filing of New
Drug Applications (NDAs) with the FDA in the U.S. For further
information please visit www.pipexinc.com.
This press release contains forward-looking statements, within
the meaning of Section 21E of the Securities Exchange Act of 1934,
that reflect Pipex Pharmaceuticals, Inc.'s current expectations
about its future results, performance, prospects and opportunities,
including statements regarding the IND filing for oral flupirtine
with the FDA, as well as initiating a phase II clinical trial for
flupirtine. Where possible, the Company has tried to identify these
forward-looking statements by using words such as "anticipates,"
"believes," "intends," or similar expressions. These statements are
subject to a number of risks, uncertainties and other factors that
could cause actual events or results in future periods to differ
materially from what is expressed in, or implied by, these
statements including the risks set forth in our Form 10-KSB and
other filings with the Securities and Exchange Commission. We
cannot assure you that we will be able to successfully develop or
commercialize products based on our technologies, including,
TRIMESTA, zinc-monocysteine, EFFIRMA (oral flupirtine), SOLOVAX,
oral TTM, or Anti-CD4 802-2, particularly in light of the
significant uncertainty inherent in developing, manufacturing and
conducting preclinical and clinical trials of new pharmaceuticals,
and obtaining regulatory approvals, that our technologies will
prove to be safe and effective, that our cash expenditures will not
exceed projected levels, that we will be able to obtain future
financing or funds when needed, that product development and
commercialization efforts will not be reduced or discontinued due
to difficulties or delays in clinical trials or due to lack of
progress or positive results from research and development efforts,
that we will be able to successfully obtain any further grants and
awards, maintain our existing grants which are subject to
performance, that we will be able to patent, register or protect
our technology from challenge and products from competition or
maintain or expand our license agreements with our current
licensors, or that our business strategy will be successful. All
forward-looking statements made in this press release are made as
of the date hereof, and the Company assumes no obligation to update
the forward-looking statements included in this news release
whether as a result of new information, future events, or
otherwise.
Lyrica� is a registered trademark of Pfizer, Inc.
For Further Information Contact: Steve H. Kanzer, CPA, Esq.
Chairman and Chief Executive Officer (734) 332-7800 Thomas
Redington Investor Relations Redington, Inc. (203) 222-7399
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